The European Medicines Agency has recommended that COVID-19 vaccines for the 2024-25 vaccination campaign should be updated to target the new JN.1 variant of the SARS-CoV-2 virus, which it says “globally overtook the previously circulating XBB family of variants between December 2023 and January 2024.”
Updated COVID-19 Vaccines Should Target New JN.1 Variant, Says EMA
Variant vaccine approvals can be based on manufacturing/quality and non-clinical data as long as data on earlier vaccines support the predictability of clinical immunogenicity and reactogenicity.
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Pharmaceutical companies are being encouraged to reach out to NICE in relation to its HTA Innovation Lab, which provides a sandbox environment in which the health technology assessment body can test new methods of evaluating “innovative and disruptive” therapies.
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The weight management drug, Mysimba, continues to demonstrate a positive benefit-risk balance but the data available are not sufficient to fully determine the cardiovascular safety beyond 12 months. Meanwhile, Currax this month announced the publication of a peer-reviewed study of Mysimba that followed patients for over 4.7 years and found no evidence of excess cardiovascular risk.
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Health technology assessment body NICE said it has taken on feedback about the implications of allowing higher cost-effectiveness thresholds for some medicines after senior health economists offered diverging views on its methods.
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Experts say PBMs should become familiar with transparency rules and prepare to release data, although more legal wrangling could occur.
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Optum Rx, one of the largest PBMs in the US, declared it was the “first comprehensive, transparent pharmacy services company” after announcing several consumer-friendly changes.
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FDA Commissioner Martin Makary was sworn in Friday and knew of the plan that ultimately lead to CBER director Peter Marks' resignation on 28 March.